- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00551395
Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion
Study Overview
Status
Conditions
Detailed Description
SLT therapy is used as an IOP lowering agent in patients with glaucoma. It is unknown whether the timing of a 2-staged approach to the laser therapy will result in better IOP lowering effect.
This study will evaluate the timing (early vs. late completion of SLT therapy) and determined the IOP lowering effect following the interventions.
Arm 1: Early Completion SLT
180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees on Day 2
Arm 2: Late Completion SLT
180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees at the 1 month follow up visit.
Primary Outcome: IOP (mmHg).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 5G2
- Hotel Dieu Hospital & Queen's University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age
- primary open angle glaucoma or pseudoexfoliation glaucoma
Exclusion Criteria:
- Unable to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SLT Early Completion (Arm 1)
Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degree on Day 2
|
180 degrees of laser on day 1 and other 180 degrees on day 2.
|
Active Comparator: SLT Late Completion (Arm 2)
Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degrees at 1 month follow up appointment.
|
180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intraocular pressure lowering
Time Frame: 1 month following procedure
|
1 month following procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intraocular pressure lowering
Time Frame: 3, 6, 12 and 24 months following procedure
|
3, 6, 12 and 24 months following procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert J Campbell, MD, Queen's University, Kingston, Canada
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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